CALIDI BIOTHERAPEUTICS, INC. Calidi Biotherapeutics Inc. (NYSE American: CLDI) (“Calidi”), a clinical-stage biotechnology company developing a new generation of targeted immunotherapies, today reported its fourth quarter and full-year 2023 operating and financial results and reviewed recent business highlights.
“Calidi continues to make great progress across our development programs while continuing to innovate and expand our industry-leading position in cell-based immunotherapies,” said Allan Camaisa, CEO and Chairman of the Board of Calidi Biotherapeutics. “We anticipate reporting an interim clinical update from our Phase 1 trial evaluating CLD-101 in high-grade glioma patients in collaboration with City of Hope in the second quarter of this year assuming we are successful in raising additional capital, and we were thrilled to recently strengthen our collaboration with City of Hope to evaluate CLD-101 for the treatment of ovarian cancer with the support of CIRM. In addition, we were proud to recently unveil our potentially paradigm-shifting advance in the treatment of advanced solid tumors, including lung cancer and metastatic disease, that required a systemic application, through our RTNova systemic delivery approach.”
Fourth Quarter 2023 and Recent Corporate Developments
- City of Hope, a leader in cancer research and treatment, was awarded $5.3 million to further support preclinical translational studies, product manufacturing (using Calidi’s next generation manufacturing process) and clinical trial design for ovarian cancer using Calidi’s licensed oncolytic virotherapy product, CLD-101. CLD-101 is a cutting-edge therapeutic candidate in Calidi’s NeuroNova program, comprising tumor-tropic neural stem cells (NSCs) that deliver an oncolytic adenovirus – CRAd-S-pk7 – selectively to tumor sites.
- Publicly announced novel systemic enveloped oncolytic virotherapy program, RTNova (CLD-400), targeting advanced solid tumors, including advanced metastatic disease. The new program builds upon Calidi’s experience using stem cells to protect oncolytic viruses from inactivation by the patient’s immune system allowing for easier administration, increased cost-effectiveness, and the ability to reach a broad patient population.
- Appointed Antonio Chiocca, M.D., Ph.D., David T. Curiel, M.D., Ph.D., and Burt L. Nabors, M.D., to the company’s Scientific and Medical Advisory Board. These physician scientists bring a deep expertise in oncology, hailing from top cancer research institutions and facilities.
- Announced the appointment of David LaPré to the company’s Board of Directors. Mr. LaPré brings significant experience in technical operations strategy and execution in the pharmaceutical industry.
- Received patent covering novel SuperNova technology platform (CLD-201) composed of adipose-derived mesenchymal stem cells loaded with oncolytic vaccinia virus. This patent strengthens the company’s robust intellectual property portfolio as Calidi plans to initiate a clinical trial in the second half of 2024. Calidi has shown preclinically the potential of SuperNova to shield the viral payload from the immune system allowing for its delivery to tumor sites.
Upcoming Anticipated Milestones
- 1H 2024: Interim clinical update from CLD-101 Phase 1 trial in collaboration with City of Hope for recurrent high-grade glioma patients
- 1H 2024: First patient dosed in CLD-101 Phase 1 trial in collaboration with Northwestern University for newly diagnosed high-grade glioma patients
- 2H 2024: First patient dosed in CLD-201 Phase 1 trial
Fourth Quarter 2023 Financial Results
The company reported a net loss of $8.2 million, or $0.23 per share, for the three months ended December 31, 2023, compared to a net loss of $7.8 million, or $0.90 per share, for the same period in 2022.
Research and development expenses were $4.0 million for the three months ended December 31, 2023, compared to $2.3 million for the comparable period in 2022, respectively.
General and administrative expenses were $5.9 million for the three months ended December 31, 2023, compared to $2.4 million for the comparable period in 2022, respectively.
Full Year 2023 Financial Results
The company reported a net loss of $29.2 million, or $1.73 per share, for the year ended December 31, 2023, compared to a net loss of $25.4 million, or $2.99 per share, for the year ended December 31, 2022.
Research and development expenses were $13.0 million for the year ended December 31, 2023, compared to $7.3 million for the year ended December 31, 2022, respectively.
General and administrative expenses were $16.0 million for the year ended December 31, 2023, compared to $15.9 million for the year ended December 31, 2022, respectively.
The company had approximately $1.9 million in cash and $0.2 million in restricted cash as of December 31, 2023, compared to $0.4 million in cash and $0.2 million in restricted cash as of December 31, 2022.
About Calidi Biotherapeutics
Calidi Biotherapeutics (NYSE American: CLDI) is a clinical-stage immuno-oncology company with proprietary technology designed to arm the immune system to fight cancer. Calidi’s novel stem cell-based platforms are utilizing potent allogeneic stem cells capable of carrying payloads of oncolytic viruses for use in multiple oncology indications, including high-grade gliomas and solid tumors. Calidi’s clinical stage off-the-shelf, universal cell-based delivery platforms are designed to protect, amplify, and potentiate oncolytic viruses leading to enhanced efficacy and improved patient safety. Calidi’s preclinical off-the-shelf enveloped virotherapies are designed to target disseminated solid tumors. This dual approach can potentially treat, or even prevent, metastatic disease. Calidi Biotherapeutics is headquartered in San Diego, California. For more information, please visit www.calidibio.com.
Forward-Looking Statements
This press release may contain forward-looking statements for purposes of the “safe harbor” provisions under the United States Private Securities Litigation Reform Act of 1995. Terms such as “anticipates,” “believe,” “continue,” “could,” “estimate,” “expect,” “intends,” “may,” “might,” “plan,” “possible,” “potential,” “predicts,” “project,” “should,” “towards,” “would” as well as similar terms, are forward-looking in nature, but the absence of these words does not mean that a statement is not forward-looking. These forward-looking statements include, but are not limited to, statements concerning upcoming key milestones (including the reporting of interim clinical results and the dosing of patients), planned clinical trials, and statements relating to the safety and efficacy of Calidi’s therapeutic candidates in development. Any forward-looking statements contained in this discussion are based on Calidi’s current expectations and beliefs concerning future developments and their potential effects and are subject to multiple risks and uncertainties that could cause actual results to differ materially and adversely from those set forth or implied in such forward-looking statements. These risks and uncertainties include, but are not limited to, the risk that Calidi is not able to raise sufficient capital to support its current and anticipated clinical trials, the risk that early results of clinical trials do not necessarily predict final results and that one or more of the clinical outcomes may materially change following more comprehensive review of the data, and as more patient data becomes available, the risk that Calidi may not receive FDA approval for some or all of its therapeutic candidates. Other risks and uncertainties are set forth in the section entitled “Risk Factors” and “Cautionary Note Regarding Forward-Looking Statements” in the Company’s Registration Statements filed with the SEC on Form S-4 filed on August 2, 2023, on Form S-1 filed on October 6, 2023, on Form S-1 filed on January 29, 2024, as amended on February 7, 2024, and on Form 10-K filed on March 15, 2024.
CALIDI BIOTHERAPEUTICS, INC. CONDENSED CONSOLIDATED BALANCE SHEETS (In thousands, except for par value data) (Unaudited) | ||||||||
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| December 31, | ||||||
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| 2023 |
| 2022 | ||||
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ASSETS |
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CURRENT ASSETS |
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Cash |
| $ | 1,949 |
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| $ | 372 |
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Prepaid expenses and other current assets |
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| 2,354 |
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| 414 |
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Total current assets |
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| 4,303 |
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|
| 786 |
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NONCURRENT ASSETS |
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Machinery and equipment, net |
|
| 1,270 |
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|
| 887 |
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Operating lease right-of-use assets, net |
|
| 4,073 |
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|
| 199 |
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Forward purchase agreement derivative asset |
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| 230 |
|
|
| — |
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Other noncurrent assets |
|
| 143 |
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|
| 725 |
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TOTAL ASSETS |
| $ | 10,019 |
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| $ | 2,597 |
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LIABILITIES, CONVERTIBLE PREFERRED STOCK AND STOCKHOLDERS’ DEFICIT |
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CURRENT LIABILITIES |
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Accounts payable |
| $ | 2,796 |
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| $ | 2,124 |
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Related party accounts payable |
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| 81 |
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| 147 |
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Accrued expenses and other current liabilities |
|
| 4,896 |
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|
| 5,142 |
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Related party accrued expenses and other current liabilities |
|
| 536 |
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|
| 205 |
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Legal settlement liability |
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| — |
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| 640 |
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Loans payable, net of issuance costs |
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| — |
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| 1,000 |
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Term notes payable, net of discount, including accrued interest |
|
| 529 |
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| 507 |
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Related party term notes payable, net of discount, including accrued interest |
|
| 278 |
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|
| 1,962 |
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Related party convertible notes payable, including accrued interest |
|
| — |
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|
| 804 |
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Related party contingently convertible notes payable, including contingently issuable warrants, at fair value |
|
| — |
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| 1,152 |
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Simple agreements for future equity (SAFE), at fair value |
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| — |
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|
| 24,575 |
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Related party SAFE, at fair value |
|
| — |
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| 4,615 |
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Finance lease liability, current |
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| 81 |
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| 72 |
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Operating lease right-of-use liability, current |
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| 1,035 |
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|
| 44 |
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Total current liabilities |
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| 10,232 |
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| 42,989 |
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NONCURRENT LIABILITIES |
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Operating lease right-of-use liability, noncurrent |
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| 3,037 |
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|
| 305 |
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Finance lease liability, noncurrent |
|
| 216 |
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|
| 142 |
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Related party term notes payable, net of discount, including accrued interest |
|
| 2,060 |
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|
| — |
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Other noncurrent liabilities |
|
| 2,038 |
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|
| — |
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Related party warrant liability |
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| 48 |
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| — |
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Warrant liability |
|
| 623 |
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|
| — |
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TOTAL LIABILITIES |
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| 18,254 |
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|
| 43,436 |
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CONVERTIBLE PREFERRED STOCK |
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| — |
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|
| 9,601 |
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STOCKHOLDERS’ DEFICIT |
| (8,235 | ) |
|
| (50,440 | ) | |
TOTAL LIABILITIES, CONVERTIBLE PREFERRED STOCK AND STOCKHOLDERS’ DEFICIT | $ | 10,019 |
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| $ | 2,597 |
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CALIDI BIOTHERAPEUTICS, INC. CONSOLIDATED STATEMENTS OF OPERATIONS (In thousands, except per share data) (Unaudited) | ||||||||
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| Year Ended December 31, | ||||||
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| 2023 |
| 2022 | ||||
REVENUE |
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Service revenues |
| $ | — |
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| $ | 45 |
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Total revenue |
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| — |
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| 45 |
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OPERATING EXPENSES |
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Cost of revenues |
|
| — |
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|
| (14 | ) |
Research and development |
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| (13,008 | ) |
|
| (7,257 | ) |
General and administrative |
|
| (15,984 | ) |
|
| (15,902 | ) |
Total operating expense |
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| (28,992 | ) |
|
| (23,173 | ) |
Loss from operations |
|
| (28,992 | ) |
|
| (23,128 | ) |
OTHER INCOME (EXPENSES), NET |
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Interest expense |
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| (329 | ) |
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| (42 | ) |
Interest expense – related party |
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| (740 | ) |
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| (116 | ) |
Series B convertible preferred stock financing costs – related party |
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| (2,680 | ) |
|
| — |
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Change in fair value of debt, other liabilities, and derivatives |
|
| (200 | ) |
|
| (1,887 | ) |
Change in fair value of debt, other liabilities, and derivatives – related party |
|
| 1,378 |
|
|
| (238 | ) |
Grant income |
|
| 2,885 |
|
|
| — |
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Debt extinguishment |
|
| (139 | ) |
|
| — |
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Debt extinguishment – related party |
|
| (332 | ) |
|
| — |
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Other income (expense), net |
|
| (51 | ) |
|
| (5 | ) |
Total other income (expenses), net |
|
| (208 | ) |
|
| (2,288 | ) |
LOSS BEFORE INCOME TAXES |
|
| (29,200 | ) |
|
| (25,416 | ) |
Income tax provision |
|
| (16 | ) |
|
| (11 | ) |
NET LOSS |
| $ | (29,216 | ) |
| $ | (25,427 | ) |
Net loss per share; basic and diluted |
| $ | (1.73 | ) |
| $ | (2.99 | ) |
Weighted average common shares outstanding; basic and diluted |
|
| 16,887 |
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| 8,505 |
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